STARTING THE PROGRAM

You must document human subjects protection at each data collection site each year. Research animal use and care documentation is also required for studies involving animals.

  • Initial and Continuing Review
  • Changes in Protocol
  • Human Subjects Protection
  • Adverse Events

INITIAL AND CONTINUING REVIEW

INITIAL REVIEW

You must submit approval from the institutional review board (IRB) and/or institutional animal care and use committee (IACUC) at each data collection site before beginning your study. You cannot spend grant money until you have submitted these forms to TSNRP, received secondary approval by the USU IRB, and received your start letter.

Following USU approval, TSNRP will send you a start letter, at which time your research project can begin.

CONTINUING REVIEW

Annual IRB/IACUC review is required for all continuing projects. You must forward documentation from each continuing review at each data collection site to TSNRP, through your grantee organization. Your study can be suspended if you fail to submit IRB documentation in a timely manner.

TSNRP developed a checklist outlining the necessary documents for secondary IRB approval. (Shaded items are required.)

ONLINE CITI TRAINING

Computer-training programs on the protection of human subjects are available from:

CHANGES IN PROTOCOL

If you need to change your research study, you must receive prior approval from TSNRP to do so. Once TSNRP approves the change, you must secure approval from your IRB(s) before implementing the change.

Your study can be suspended or terminated if you fail to seek appropriate approvals.

HUMAN SUBJECTS PROTECTION

All members of research teams that come in contact with human subjects must attend an education/training program to comply with the Department of Defense (DoD) directive for the protection of human subjects in DoD-supported research (Number 3216.2, March 25, 2002).

You must ensure that your research team members receive human subjects protection training and forward certifications to TSNRP prior to initiating your research study.

Many institutions have developed their own education and training course for the protection of human subjects. If you or any of your team members have already received such training, forward a copy of the certifications.

All team members must certify familiarity and compliance with:

Complete and sign the Ethical Standards in Research Involving Human Subjects form and forward it to tsnrp@usuhs.edu.

ADVERSE EVENTS

Problems involving risk to participants, including animals, may occur during the course of your research study and require appropriate and timely responses. They include physical and psychological harm to humans and animals.

Adverse events include but are not limited to:

  • An event or problem that affects the safety and welfare of study participants.
  • An unexpected problem, complication, or death resulting from the research procedures described in the IRB-approved protocol and related or possibly related to participation in the research study.
  • Any change in U.S. Food and Drug Administration safety labeling or withdrawal of a drug, device, or biologic agent used in an IRB–approved research study due to adverse events or unanticipated problems.
  • Accidental or unintentional change to or noncompliance with the IRB-approved protocol without prior sponsor and IRB approval.
  • Any breach in confidentiality that caused harm or places study participants or others at a greater risk of harm (including physical, psychological, economic, or social), such as a data breach.
  • Any unanticipated incident that seriously affects the health or safety of laboratory animals.
  • Any unanticipated loss of animal life.
  • Any work-related injury to persons involved in animal research or any other person that requires more than minor medical intervention.

Federal regulations governing the use of humans in research state the institution that granted local approval to conduct the study must have "written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head, of any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB" (Code of Federal Regulations, 2009).

The definition of "prompt" and "unanticipated problems" can leave you questioning what and when to report. "Clearly, any unanticipated problem involving 'risk' that ultimately results in harm to the subject and is related to a research intervention encompasses a reportable AE" (Prentice, Epperson, Kratochvil, & Gordon, 2002).

When an unanticipated event occurs, you must initially decide whether the event is related to the research, can be categorized into a series of similar events resulting in a need to change the protocol and/or consent form, or is serious enough to require reporting to the local IRB. If it is serious, you must immediately report the event. If you have any doubt about whether a problem involved risk, TSNRP urges seeking guidance from the local IRB. When in doubt, ask!

Local IRB policies vary, and differences occur within the same military service. The principal investigator is responsible for each study site, each site's IRB policies, and each study investigator. Keep a copy of the policies for all sites in the study file. All investigators must know and follow local IRB policies. The principal investigator is responsible for the accurate documentation, investigation, and follow-up of all possible study–related adverse events.

If an adverse event occurs on your TSNRP study, follow your local IRB's instructions for reporting the event. Additionally, fax TSNRP a copy of the local IRB's notification within 24–48 hours of the event; the notification will be forwarded for secondary IRB review at USU.